跳至主要内容
临床试验/NCT06981650
NCT06981650尚未招募不适用

Video Education to Improve First Time Colonoscopy Outcomes: A Prospective Randomized Control Trial.

New York City Health and Hospitals Corporation0 个研究点目标入组 362 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
362
主要终点
Boston Bowel Preparation Scale (continuous)

研究概览

简要总结

The investigators compare video education plus standard education versus standard education for bowel preparation before a colonoscopy. The primary outcome will be the quality of bowel preparation.

详细描述

The investigators compare video education plus standard education versus standard education for bowel preparation before a colonoscopy and include a number of languages including English, Spanish, Russian, Haitian Creole, and Urdu. The educational content also includes psychological content based upon the Theory of Planned Behavior. The primary outcome will be the quality of bowel preparation, as measured by the Boston Bowel Preparation Scale (BBPS) score,

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all outpatients aged 18 to 75 years scheduled for their first screening colonoscopy

排除标准

  • ● Contraindications for colonoscopy
  • History of bowel surgery, particularly colorectal surgery
  • Severe comorbid conditions (e.g., impaired hepatic, renal or bone marrow function, congestive heart failure, recent coronary artery disease)
  • Chronic constipation (typically <3 bowel movements per week with hard stools, a feeling of incomplete evacuation, or abdominal discomfort) requiring the use of laxatives
  • Pregnancy or lactation
  • Prisoners
  • Diagnosis of inflammatory bowel disease
  • Inability to use video presentation devices (e.g., blindness)
  • Active cancers.

结局指标

主要结局

Boston Bowel Preparation Scale (continuous)

时间窗: Perioperative/Periprocedural

Quality of bowel preparation measured by the Boston Bowel Preparation Scale. Scores range from 0 through 3. Higher scores indicate a better outcome..

次要结局

  • Boston Bowel Preparation Scale (categorical)(Perioperative/Periprocedural)
  • Polyp detection rate proportion(Perioperative/Periprocedural)
  • Adenoma detection rate proportion(Perioperative/Periprocedural)
  • Adherence to bowel preparation instructions(Perioperative/Periprocedural)
  • Amsterdam Preoperative Anxiety and Information Scale(baseline)
  • Overall experience with the bowel preparation process(Perioperative/Periprocedural)
  • Desire to undergo future colonoscopies if indicated(Perioperative/Periprocedural)
  • Cecal intubation rate proportion(Perioperative/Periprocedural)
  • Withdrawal time(Perioperative/Periprocedural)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Trillo

Director of Gastroenetrology, South Brooklyn Health

New York City Health and Hospitals Corporation

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